Evaluating the Safety and Immunogenicity of an HIV Vaccine (gp145 C.6980) in Healthy, HIV-Uninfec… (NCT03382418) | Clinical Trial Compass
CompletedPhase 1
Evaluating the Safety and Immunogenicity of an HIV Vaccine (gp145 C.6980) in Healthy, HIV-Uninfected Adults in the United States
United States45 participantsStarted 2017-12-27
Plain-language summary
The purpose of this study is to evaluate the safety, tolerability, and immunogenicity of an HIV vaccine (gp145 C.6980) with aluminum hydroxide adjuvant in healthy, HIV-1-uninfected adults in the United States.
Who can participate
Age range
18 Years – 50 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
General and Demographic Criteria
* Age of 18 to 50 years
* Access to a participating HIV Vaccine Trials Network (HVTN) clinical research site (CRS) and willingness to be followed for the planned duration of the study
* Ability and willingness to provide informed consent
* Assessment of understanding: volunteer demonstrates understanding of this study and completes a questionnaire prior to first vaccination with verbal demonstration of understanding of all questionnaire items initially answered incorrectly
* Agrees not to enroll in another study of an investigational research agent before the last scheduled protocol clinic visit
* Good general health as shown by medical history, physical exam, and screening laboratory tests
HIV-Related Criteria:
* Willingness to receive HIV test results
* Willingness to discuss HIV infection risks and amenable to HIV risk reduction counseling.
* Assessed by the clinic staff as being at "low risk" for HIV infection and committed to maintaining behavior consistent with low risk of HIV exposure through the last required protocol clinic visit. Low risk guidelines are found on the protocol web page under Study Materials on the HVTN Members' site (https://members.hvtn.org/protocols/hvtn122).
Laboratory Inclusion Values
Hemogram/Complete Blood Count (CBC)
* Hemoglobin greater than or equal to 11.0 g/dL for volunteers who were born female, greater than or equal to 13.0 g/dL for volunteers who were born male
* White blood cel…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or Tenderness
Timeframe: Measured through 7 days after first vaccination at Month 0
2
Number of Participants Reporting Local Reactogenicity Signs and Symptoms:Erythema and/or Induration
Timeframe: Measured through 7 days after first vaccination at Month 0
3
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Timeframe: Measured through 7 days after first vaccination at Month 0
4
Number of Participants Reporting Adverse Events (AEs), by Severity Grade
Timeframe: Measured through 30 days after first vaccination at Month 0
5
Number of Participants Reporting Adverse Events (AEs), by Relationship to Study Product
Timeframe: Measured through 30 days after first vaccination at Month 0
6
Number of Participants Reporting Serious Adverse Events (SAEs)
Timeframe: Measured through 30 days after first vaccination at Month 0
7
Trial details
NCT IDNCT03382418
SponsorNational Institute of Allergy and Infectious Diseases (NIAID)